Continuous Glucose Monitoring for the Management of Hyperglycemia in Patients With Glioblastoma

Study Purpose

This clinical trial studies whether continuous glucose monitoring (CGM) can be used to help patients with glioblastoma manage their blood sugar (glucose) levels and improve survival. Glioblastoma is the most common malignant primary brain tumor in adults, with an average survival time of approximately 15-18 months despite therapy. Studies have shown that having a higher-than-normal amount of glucose in the blood (hyperglycemia) during radiation therapy is associated with poorer survival outcomes in glioblastoma patients. Hyperglycemia in glioblastoma patients is often driven by steroids that are commonly used during treatment. CGM uses a device that places a sensor under the skin that monitors glucose levels at regular intervals, providing real-time, or near real-time, glucose information. This can help to identify when a patient has changes in their glucose levels so they may receive necessary interventions or medications sooner. CGM may be an effective way for glioblastoma patients to manage their glucose levels, which may improve survival.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Histologically confirmed newly diagnosed glioblastoma (World Health Organization [WHO] grade IV) - IDH-wildtype status confirmed by molecular testing.

- Age ≥ 18 years at the time of consent.

- Karnofsky performance status (KPS) ≥ 70 at baseline.

- Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L.

- Platelet count ≥ 100 × 10^9/L.

- Hemoglobin ≥ 9 g/dL.

- Serum creatinine ≤ 1.5 × upper limit of normal (ULN) or creatinine clearance ≥ 60 mL/min.

- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN.

- Total bilirubin ≤ 1.5 × ULN.

- Willingness and ability to comply with CGM device use and attend dietary counseling sessions as part of the study protocol.

Exclusion Criteria:

- Recurrent glioblastoma or prior therapy for glioblastoma beyond surgical resection or biopsy.

- History of eating disorders (e.g., anorexia nervosa, bulimia) or substance use disorder within the past 12 months.

- Any other uncontrolled or inadequately managed medical illness (e.g., unstable cardiovascular, hepatic, renal, or psychiatric condition) that, in the opinion of the investigator, would interfere with study participation or interpretation of results.

- Concurrent diagnosis of another active malignancy requiring treatment.

- Pregnancy or breastfeeding at the time of enrollment.

- Documented history of type 1 diabetes mellitus

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT07091864
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Mayo Clinic
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Gelareh Zadeh, MD, PhD
Principal Investigator Affiliation	Mayo Clinic in Rochester
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioblastoma, IDH-Wildtype, WHO Grade 4 Glioma
Study Website:	View Trial Website

Arms & Interventions

Arms

Experimental: Arm A (SOC, CGM)

Patients receive SOC treatment plus CGM with endocrinology-guided interventions as needed and attend dietary counseling sessions once a month for up to 52 weeks in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection and MRI throughout the trial.

Active Comparator: Arm B (SOC, intermittent glucose monitoring)

Patients receive SOC treatment plus intermittent glucose monitoring as clinically indicated for up to 52 weeks in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection and MRI throughout the trial.

Interventions

Other: - Best Practice

Receive SOC treatment

Procedure: - Biospecimen Collection

Undergo blood sample collection

Other: - Dietary Intervention

Attend dietary counseling sessions

Other: - Glucose Measurement

Undergo intermittent glucose monitoring

Procedure: - Magnetic Resonance Imaging

Undergo MRI

Other: - Monitoring

Undergo CGM

Other: - Questionnaire Administration

Ancillary studies

Other: - Supportive Care

Receive endocrinology-guided interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Mayo Clinic in Rochester, Rochester 5043473, Minnesota 5037779

Status

Address

Mayo Clinic in Rochester

Rochester 5043473, Minnesota 5037779, 55905

Site Contact

Clinical Trials Referral Office

[email protected]

855-776-0015

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